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This testimony discusses the Agency for Toxic Substances and Disease Registry's (ATSDR) policies and procedures for product preparation. ATSDR investigates community exposures related to chemical sites and releases; works with federal, tribal, state, and local agencies to identify potential exposures; assesses associated health effects; and recommends actions to stop, prevent, or minimize these harmful effects. In conducting these activities, the agency publishes many types of public health products, including public health assessments, health consultations, health study reports, and exposure investigations. Recent reports by the Institute of Medicine and ATSDR's Board of Scientific Counselors have identified various concerns such as the appropriateness and quality of the data used in ATSDR's products, the methodology and design of the studies, and clearance policies. This committee has held two previous hearings that focused on its concern about the quality of ATSDR's products. In response, ATSDR has noted that multiple factors have posed challenges for the agency, including limitations in the ability of available science to answer community questions about the effect of chemical exposures, limitations in ATSDR's ability to collect data related to exposures, and reductions since 2004 in the number of ATSDR staff and resources available to conduct the agency's mission. This testimony addresses the extent to which ATSDR's policies and procedures for product initiation, development, and review and clearance provide reasonable assurance of public health product quality.

We found that the policies and procedures that ATSDR has established for public health product preparation lack some of the critical controls to provide reasonable assurance of product quality. To provide reasonable assurance that agency objectives are being met, federal internal control standards call for agencies to establish policies and procedures, assess risks associated with achieving agency objectives, ensure effective information sharing throughout the organization, monitor agency activities, and establish key areas of authority and responsibility for management and staff. We found that ATSDR's policies and procedures are deficient in the three phases of preparation of public health products: (1) initiation, which includes a decision by the agency to begin work on a public health product and the assignment of staff to prepare the product; (2) development, which includes management approval to proceed with the development of a product and the actual drafting of the public health product; and (3) review and clearance, which is the process by which a product is internally or externally reviewed and disseminated as a final public health product.